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Acclarent Pivot

FDA UDI

Class II (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name
ACCLARENT PIVOT FDA UDI
Generic Name
Eustachian catheter, single-use FDA UDI
Device Name
ACCLARENT PIVOT Illumination Balloon Dilation System FDA UDI
Model / Reference
PVT0616L FDA UDI
Description
ACCLARENT PIVOT Illumination Balloon Dilation System FDA UDI

Identifiers

Catalog Number
PVT0616L FDA UDI
Primary DI / UDI-DI
10705031465572 FDA UDI
510(k) Number
K201115 FDA UDI
FDA Product Code
PNZ FDA UDI
PGW FDA UDI
LRC FDA UDI
GMDN Term
Eustachian catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4180 FDA UDI
882.4560 FDA UDI
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Eustachian catheter, single-use

Acclarent Pivot by Acclarent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eustachian catheter, single-use.

Cleared under the same submission

K201115 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acclarent, Inc.

Sources (1)

  • FDA UDI ab564df3-9536-449b-9d39-7ed44ce78b51 37 fields · synced May 30, 2026